Intra-vaginal device withdrawal assembly

ABSTRACT

An intravaginal device having an aperture and a withdrawal assembly. The withdrawal assembly has a withdrawal member and an obstruction.

FIELD OF INVENTION

This application relates to a withdrawal assembly for an intravaginaldevice.

BACKGROUND OF THE INVENTION

Intravaginal devices are inserted inside the vaginal canal for manydifferent purposes from absorbing menses to managing urinaryincontinence. Such devices are designed for arrangement in the vaginaand must be removed after a prescribed duration of use. A withdrawalassembly can be joined to the intravaginal device to ease with removalof the device. The withdrawal assembly should remain attached to thedevice. As such, there remains a need to join the withdrawal assembly ina manner that secures the withdrawal assembly and allows for ease ofremoval.

SUMMARY OF THE INVENTION

A pessary device is provided. The pessary device has an outer shell, ahollow region, and an aperture to the hollow region. The hollow regionhas a withdrawal assembly and at least a first pair of protuberances anda second pair of protuberances. The withdrawal assembly has a withdrawalmember and an obstruction having a main body and at least twoextensions. The second pair of protuberances at least partially blocksthe aperture.

Also provided is a pessary device having a top, a base, a length, alongitudinal axis, a transverse axis, a hollow region, an aperture tothe hollow region, and a withdrawal assembly. The withdrawal assemblyhas a withdrawal member and an obstruction. The obstruction has an outerlength, an outer height, and an outer width. At least one of theobstruction outer length, obstruction outer width, or obstruction outerheight is greater than the largest dimension of the aperture.

Further provided is a pessary device comprising a top, a base, a length,a longitudinal axis, a transverse axis, a hollow region, and an apertureto the hollow region. The hollow region has a withdrawal assembly and atleast a first pair of protuberances and a second pair of protuberances.The withdrawal assembly has a withdrawal member and an obstructioncomprising a main body, at least two extensions, an outer length, anouter height, and an outer width. At least one of the obstruction outerlength, obstruction outer width, or obstruction outer height is greaterthan the largest dimension of the aperture and the second pair ofprotuberances at least partially blocks the aperture.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the subject matter of the present invention, itis believed that the invention can be more readily understood from thefollowing description taken in connection with the accompanyingdrawings, in which:

FIGS. 1A-C are examples of a withdrawal assembly.

FIGS. 2A-M are examples of obstructions.

FIG. 3 exemplifies a finished tampon.

FIG. 4 exemplifies a tampon pledget in a flat-out, uncompressed state.

FIG. 5 exemplifies a tampon pledget in a flat-out, uncompressed state.

FIG. 6 exemplifies a tampon pledget in a flat-out, uncompressed state.

FIG. 7A is a side view of a pessary device.

FIG. 7B is a perspective view of the pessary device of FIG. 7A.

FIG. 8 is a cross section view of a pessary device as taken through line8-8 in FIG. 7A.

FIGS. 9A-E are cross-section views of a pessary device with a withdrawalassembly.

FIG. 10 is a side view of a pessary device.

FIG. 11 is a side view of an applicator.

FIG. 12 is a top view of a portion of FIG. 2M.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to a withdrawal assembly for anintravaginal device having an aperture. The withdrawal assembly has awithdrawal member and an obstruction. The obstruction can at leastpartially block the aperture in the intravaginal device thereby joiningthe withdrawal member to the intravaginal device.

The withdrawal assembly has a withdrawal member for ease of removalafter use of the intravaginal device. The withdrawal member can bejoined to an obstruction. The obstruction can have an insertion mode anda functional mode. The insertion mode can be a non-expanded mode. Thefunctional mode can be an expanded mode. The obstruction can becompressible. The obstruction can be flexible. The obstruction can becontained inside the intravaginal device. The obstruction can be part ofthe outer profile of the intravaginal device. The obstruction can besurrounded by the intravaginal device.

The obstruction can be contained inside the intravaginal device by anyaperture opening to the hollow interior of a device. The obstruction canbe contained inside the intravaginal device by the shape of theintravaginal device. For example, if the intravaginal device is a hollowpessary, the obstruction can be contained inside the device by a waistof the pessary device itself. The obstruction can also be containedinside the device by one or more internal protuberances within a hollowinterior of an intravaginal device.

As used herein, “applicator” refers to a device or implement thatfacilitates the insertion of the intravaginal device into an externalorifice of a mammal. Exemplary applicators include telescoping, tube andplunger, and compact applicators.

The term “joined” or “attached,” as used herein, encompassesconfigurations in which a first element is directly secured to a secondelement by affixing the first element directly to the second element;configurations in which the first element is indirectly secured to thesecond element by affixing the first element to intermediate member(s)which in turn are affixed to, encompassed by, or enrobed by the secondelement; and configurations in which first element is integral withsecond element, i.e., first element is essentially part of the secondelement.

The term “compressed,” as used herein, refers to pressing or squeezingtogether or otherwise manipulating the size, shape, and/or volume.

As used herein, “fluid wicking” refers to the ability of a material tocarry fluid or moisture by capillary action. The fluid wicking capacityof a medium can be measured by grams of fluid drawn per gram of tamponweight over a fixed period of time.

As used herein, the term “intravaginal device” refers to a deviceinserted inside the vaginal canal. Intravaginal devices include but arenot limited to: tampons, pessary devices, devices for drug delivery,intrauterine devices, and/or birth control devices.

As used herein, the term “non-expandable” refers to devices that do notexpand prior to or during use, such as, for example, devices that do notincrease in size or volume prior to or during use. For example,non-expandable devices have a diameter and/or volume that do notincrease. In contrast, “expandable”, as used herein, refers to devicesthat do expand prior to or during use, such as, for example, devicesthat do increase in size or volume prior to or during use, such as, forexample, devices that increase in diameter and/or length, absorb fluidinto a fibrous or absorbent gelling material structure, or otherwisechange from a first size or volume to a second size or volume, such as,for example, by inflation, absorption, mechanically, or by other means.Insubstantial changes to a non-expandable device as a result of anythermal expansion that could occur at body temperatures are notconsidered expansions.

A “pessary device,” or more particularly an “incontinence pessarydevice,” as used herein, refers to devices specifically designed,configured, and/or adapted for placement into a vagina in order toreduce the occurrence and/or severity of female urinary incontinence. A“pessary device” can include any type of substantially non-absorbentstructure for the purpose of reducing urine leakage and/or supporting aprolapsed uterus and/or bladder. A pessary device does not include amenstrual tampon.

As used herein, the term “protuberances” refers to something that bulgesout or that projects from its surroundings.

The terms “pledget” and “tampon pledget,” as used herein, refer to aconstruction of absorbent material prior to the compression of suchconstruction into a tampon as described below. Tampon pledgets aresometimes referred to as tampon “blanks” or a “softwind,” and the term“pledget” is intended to include such terms as well.

The term “tampon,” as used herein, refers to any type of absorbentstructure that is inserted into the vaginal cavity or other bodycavities for the absorption of fluid therefrom. Typically, tampons areconstructed from a generally elongated absorbent member that has beencompressed and/or formed into a vaginally insertable shape.

As used herein, the term “vaginal canal” refers to the internalgenitalia of the human female in the pudendal region of the body. Theterms “vaginal canal” or “within the vagina,” as used herein, areintended to refer to the space located between the introitus of thevagina (sometimes referred to as the sphincter of the vagina) and thecervix.

As used herein, “cm” is centimeter, “mm” is millimeter, “g” is gram,“gsm” is grams per meter squared, “dpf” is denier per fiber, “g/g” isgram of fluid per gram of sample, “wt” is weight, “psi” is pound persquare inch.

Withdrawal Assembly

FIGS. 1A-C are examples of a withdrawal assembly 28. The withdrawalassembly 28 has a withdrawal member 310 and an obstruction 312.

The withdrawal member 310 can comprise any suitable material including,for example: cotton, cellulose, rayon, polyolefins such as, for example,polyethylene or polypropylene, nylon, silk, polytetrafluoroethylene,wax, or any other suitable materials.

The withdrawal member 310 can be non-absorbent. As used herein, the term“non-absorbent” refers to a structure that does not retain a significantportion of deposited fluid in its structure. The withdrawal member 310can be inherently non-wettable or hydrophobic, or can be treated toprovide such properties. For example, a coating of wax can be applied tothe withdrawal member 310 to decrease or eliminate its absorbency. Thewithdrawal member 310 need not necessarily be non-fluid wicking, even ifa non-absorbent withdrawal member 310 is desired.

The withdrawal member 310 can be any suitable length, such as, forexample, a length from about 100 mm to about 500 mm, about 200 mm toabout 400 mm, such as, for example, about 150 mm, about 175 mm, about200 mm, about 225 mm, about 250 mm, about 275 mm, about 300 mm, about325 mm, about 350 mm, about 375 mm, about 400 mm, about 425 mm, about450 mm, about 475 mm, or about 500 mm.

The withdrawal member 310 can be formed by any suitable formation methodand in any suitable configuration, such as, for example, one or morecords, strings, finger covers, ribbons, an extension of a material ofthe intravaginal device, or combinations thereof.

The withdrawal assembly 28 can have an obstruction 312. The withdrawalmember 310 can be joined to the obstruction 312. The withdrawal member310 can go through the obstruction 312. The obstruction 312 can bemolded around the withdrawal member 310. The obstruction 312 can be partof the withdrawal member 310. The withdrawal member 310 can be moldedaround the obstruction 312. The withdrawal member 310 can be joined tothe obstruction 312 such that, placing forces on the withdrawal member310 can cause the obstruction 312 to expand. The obstruction 312 can bemade of any suitable material. The obstruction 312 can be formed frompolymeric materials, such as, for example, polycarbonate, polyester,polyethylene, polyacrylamide, polyformaldehyde, polymethylmethacrylate,polypropylene, polytetrafluoroethylene, polytrifluorochlorethylene,polyvinylchloride, polyurethane, nylon, silicone, or mixtures or blendsthereof, or metallic materials. The obstruction 312 can be formed frompart of the withdrawal member 310.

As shown in FIG. 2A-L, the obstruction 312 can be any suitable shape.The obstruction 312 can be, for example, a disk, a cone, a star, a jack,a ball, a dumb bell, a drum, or a cross. The obstruction 312 cancomprise of one or more interconnected parts. The obstruction 312 can bea hook or multiple hooks. As shown in FIG. 2M, in an embodiment, theobstruction 312 may have a main portion 318 with extensions 316. Themain portion may be a cylinder, an obelisk, a rectangle, or any othershape wherein at least one dimension of length, width, and height isgreater than the other two dimensions. In an embodiment, the mainportion 318 may contain a recess on the end opposing the extensions 316.In an embodiment, the main portion 318 may be hollow with an opening tothe hollow interior on the end opposing the extensions 316.

FIG. 12 represents a top view of a portion of FIG. 2M. As shown in FIG.12, the obstruction 312 may have slots 314 designed to fit thewithdrawal member 310. The slots 314 may be formed by a gap between twomore extensions 316 from the main portion 318 or within an extension 316of the obstruction 312. The obstruction may have more than one slot 314depending on the number of extensions 316. As shown in FIG. 12, anobstruction 312 with three extensions 316 may have three slots 314. Inan embodiment, the obstruction may have between two and ten extensions.

The obstruction 312 can have an insertion mode and a functional mode.The insertion mode can be the obstruction 312 in a non-expanded mode.The obstruction 312 can be compressible. The obstruction 312 can beflexible. The functional mode can be a volumetrically expanded mode. Theobstruction 312 can transition between the insertion mode and thefunctional mode by hinge points in the obstruction 312 allowing theobstruction 312 to change volumetrically.

The withdrawal assembly 28 can be used with any intravaginal devicehaving an aperture in the intravaginal device. The obstruction 312 canbe located on one end of the aperture. The withdrawal member 310 cancross through the aperture. The withdrawal assembly 28 can be used withintravaginal devices such as, for example, tampons and pessaries.

Tampon

FIG. 3 exemplifies a finished tampon 11 made from a pledget of thepresent invention. The present invention, however, is not limited to astructure having the particular configuration shown in the drawings. Thetampon 11 can comprise a compressed absorbent member 12 comprisingabsorbent material 31, and an overwrap 41 that substantially covers theabsorbent material 31 of the compressed absorbent member 12. The tamponcan be rolled construction or flat pad construction. The tampon 11 caninclude a withdrawal assembly 28 having an obstruction 312 and awithdrawal member 310 extending beyond the tampon withdrawal end 38. Theobstruction 312 is not sown to the absorbent material 31. Theobstruction 312 can be held by friction within the tampon 11. Theobstruction 312 can be contained within the compressed absorbent member12 by the overwrap 41.

Absorbent Material

FIG. 4 exemplifies a tampon pledget 21 in a flat-out, uncompressedstate. The absorbent material 31 of the present invention forms a tamponpledget 21. The tampon pledget 21 comprises an insertion end 36, awithdrawal end 38, a first longitudinal edge 24, and a secondlongitudinal edge 25. A withdrawal assembly 28 having an obstruction 312and a withdrawal member 310 that crosses through an aperture 314 in theabsorbent material 31. Compression of a tampon pledget 21 can form acompressed absorbent member 12 (as shown in FIG. 3). A compressedabsorbent member 12 in combination with a withdrawal assembly 28 canform a tampon 11 (as shown in FIG. 3). The pledget 21 can have anoverwrap 41 and an additional optional second overwrap 44.

The overwrap may comprise a fibrous liquid permeable non-woven materialcomprising a blend of synthetic and natural fibers. The synthetic fibersmay include, but are not limited to, fibers such as polyester,polyolefin, nylon, polypropylene, polyethylene, polyacrylic, celluloseacetate, or bicomponent fibers. Natural fibers may include, but are notlimited to, those commonly known to be non-synthetic and of naturalorigin such as cotton and/or rayon. In general, the natural fibers mayprovide ready absorption and fluid wicking strength. The ratio ofsynthetic fibers to natural fibers may fall in the range of from about90:10 to about 30:70. Alternatively, the ratio of synthetic fibers tonatural fibers may fall in the range of from about 70:30 to about 40:60.The synthetic fibers may have hydrophobic and/or hydrophilic surfaces.The synthetic fibers may be inherently hydrophilic, or may preferably betreated to provide such properties.

The tampon pledget 21 can be any suitable shape, size, material, orconstruction for compression or formation into a tampon 11 having avaginally insertable shape. The absorbent material 31 can be generallysquare or rectangular or take on other shapes such as trapezoidal,triangular, hemispherical, chevron, or hourglass shapes.

The tampon pledget 21 can be a batt of absorbent material 31 in anysuitable shape. For example, the pledget 21 can be generally “H” shaped,such as shown in FIG. 5. A “bow tie” shaped tampon pledget 21, such asis shown in FIG. 6, is also suitable. The tampon pledget 21 can be agenerally “chevron shaped” pad of absorbent material 31. While a chevronshaped pledget 21 can be suitable, the edges of the chevron can besomewhat “rounded off” in order to facilitate high speed manufacturingoperations. Other shapes such as trapezoidal, triangular, semi-circular,and rectangular shaped are also acceptable. As show in FIGS. 5 and 6,the pledget 21 has an aperture 314 and a withdrawal assembly 28. Thewithdrawal assembly 28 has an obstruction 312 and a withdrawal member310. The obstruction 312 at least partially blocks the aperture 314. Thewithdrawal member 310 crosses through the aperture 314.

As an alternative to the shapes of pledgets 21 described above, a tamponpledget 21 of the present invention can have a uniform shape such as arectangular shape but can vary in absorbent material 31 thickness alongthe axial extent of the pledget 21.

The tampon pledget 21 can be constructed from a wide variety ofliquid-absorbing materials commonly used in absorbent articles such asrayon (including tri-lobal and conventional rayon fibers), cotton, orcomminuted wood pulp which is generally referred to as airfelt. Examplesof other suitable absorbent materials include, but are not limited to,creped cellulose wadding; meltblown polymers including coform;chemically stiffened, modified, or cross-linked cellulosic fibers;synthetic fibers such as crimped polyester fibers; peat moss; foam;tissue including tissue wraps and tissue laminates; or any equivalentmaterial or combinations of materials, or mixtures thereof.

Typical absorbent materials can comprise cotton, rayon folded tissues,woven materials, non-woven webs, synthetic and/or natural fibers orsheeting. The tampon 11 and any component thereof can comprise a singlematerial or a combination of materials. Additionally, superabsorbentmaterials, such as superabsorbent polymers or absorbent gelling andopen-celled foam materials can be incorporated into the tampon 11.

The absorbent material 31 and resulting compressed absorbent member 12(shown in FIG. 3) can comprise rayon, cotton, or combinations of bothmaterials. These materials have a proven record of suitability for usein the human body. The rayon used in the absorbent material 31 can beany suitable type typically used in disposable absorbent articlesintended for in vivo use. Such acceptable types of rayon include GALAXYRayon (a tri-lobed rayon structure) available as 6140 Rayon from AcordisFibers Ltd., of Hollywall, England. SARILLE L rayon (a round fiberrayon), also available from Acordis Fibers Ltd. is also suitable. Anysuitable cotton material can be used in the absorbent material 31.Suitable cotton materials include, long fiber cotton, short fibercotton, cotton linters, T-fiber cotton, card strips, and comber cotton.The cotton can be scoured and bleached cotton absorbent with a glycerinfinish, or other suitable finish.

The absorbent material 31 can be a laminar structure comprised ofintegral or discrete layers. If the compressed absorbent member 12 ofthe present invention is layered, the layers can comprise differentmaterials. For example, the outer layers can comprise primarily rayon,while the intermediate layer or layers can comprise primarily cotton.Optionally, the entire compressed absorbent member 12 can comprise auniform or non-uniform blend of materials throughout. The absorbentmaterial can comprise 100% rayon fibers or 100% cotton fibers. Theabsorbent material can comprise a combination of rayon and cotton fibersin any suitable combination. The absorbent material can comprise greaterthan about 25%, 30%, or 40% rayon fibers and the balance of theabsorbent material comprising cotton fibers. The absorbent material ofthe present invention can comprise greater than about 50% rayon fiberswith cotton fibers comprising the balance of the absorbent material. Theabsorbent material can comprise greater than about 60, 70, 75, 80, or90% rayon fibers and the balance of the absorbent material comprisingcotton fibers. Each of the layers can comprise essentially 100% of thesame material, such as outer layers of 100% rayon and an intermediatelayer of 100% cotton. A Super Plus absorbency tampon of the presentinvention can be made from a pledget comprising about 100% rayon fibers.A Super absorbency or Regular absorbency tampon of the present inventioncan be made from a pledget comprising about 25% cotton and about 75%rayon fibers. A Junior absorbency tampon can be made from a pledgetcomprising about 50% cotton and about 50% rayon fibers.

A typical size for absorbent material 31 prior to compression can befrom about 30 or 40 mm to about 60, 70, 80, 90, or 100 mm in length andfrom about 40 or 50 mm to about 70, 75, 80, 85, or 90 mm in width. Thetypical range for the overall basis weight can be from about 150, 200,or 250 gsm to about 600, 800, 1000, or 1100 gsm.

As shown in FIGS. 4 to 6, one or more layers of the tampon pledget 21have an aperture 314. The aperture 314 may be any suitable size suchthat the one dimension of the obstruction 312 is larger than onedimension of the aperture 314. The withdrawal member 310 crosses throughthe aperture 314.

Optional Tampon Components

The tampon 11 can include an additional overwrap 44 as shown in FIG. 4.This additional overwrap can substantially cover the overwrap 41 thatsubstantially covers the exterior surface of the compressed absorbentmember 12 of the tampon 11. This additional overwrap can be added priorto or subsequent to compression of the absorbent material to form acompressed absorbent member.

The tampon 11 can be inserted digitally or through the use of anapplicator as shown in FIG. 11. Any of the currently available tamponapplicators can also be used for insertion of the tampon 11. Suchapplicators of typically a “tube and plunger” type arrangement can beplastic, paper, or other suitable material. Additionally, a “compact”type applicator is also suitable.

Pessary Device

An exemplary pessary device 10 is shown in FIGS. 7A and 7B. The pessarydevice 10 includes an upper portion 20, a lower portion 30, a middleportion 40, a pressure region 50 of the upper portion 20, a pressureregion 60 of the lower portion 30, a maximum diameter D₁, a minimumdiameter D₂, a slope 80 extending from the upper portion 20 to themiddle portion 40, a slope 90 from the middle portion 40 to the lowerportion 30, a longitudinal axis (L) and a transverse axis (T). As shownin FIGS. 7A and 7B, the pessary device 10 can have a top 100 thatincludes a convex portion 110, a base 120 that includes a convex portion130, and sides 140 that include concave portions 150. The pessary devicecan be symmetric about the longitudinal axis, including for example,wherein the base is circular and symmetric about the longitudinal axis.The pessary device can include a third diameter D₃ that is greater thanminimum diameter D₂, and convex portion 110 can be aligned with maximumdiameter D₁ to provide pressure region 50, and convex portion 130 can bealigned with maximum diameter D₃ to provide pressure region 60. Inaddition, concave portion 150 can be aligned with minimum diameter D₂ toform flexile region 160.

FIG. 8 shows a cross section of the pessary device 10 as taken throughline 8-8 in FIG. 7A. The pessary device 10 includes an upper portion 20,a lower portion 30, a middle portion 40, a pressure region 50 of theupper portion 20, a pressure region 60 of the lower portion 30, amaximum diameter D₁, a minimum diameter D₂, a slope 80 extending fromthe upper portion 20 to the middle portion 40, a slope 90 from themiddle portion 40 to the lower portion 30, and a longitudinal axis (L).As shown in FIG. 8, the pessary device 10 can have a top 100 thatincludes a convex portion 110, a base 120 that includes a convex portion130, and sides 140 that include concave portions 150. As shown in FIG.8, the pessary device 10 can have an interior 200 that is hollow. Thepessary device has inner walls 240 that define interior 200 and hollowregion 220. The hollow region 220 can have one or more protuberances 260extending from the inner wall 240. In addition, the inner walls 240 canhave the same or a similar profile as the outer walls 250.

FIGS. 9A-E show cross sections of multiple pessary devices 10 takenalong line 8-8 of FIG. 7A having a withdrawal assembly 28. The pessarydevices 10 can have an interior 200 that is hollow. In addition, asshown in FIGS. 9A-E, the pessary device 10 can have an aperture 314 onone or more of top 100 and/or on base 120. As shown in FIGS. 9A-C, thepessary device 10 can have a longitudinal axis L and a transverse axisT.

As shown in FIGS. 9A-E, The intravaginal device can comprise an aperture314. The aperture 314 can be through any surface of the intravaginaldevice. The aperture 314 can be between the outside of a hollowintravaginal device to the hollow interior. The aperture 314 can bebetween an inner layer and an outer layer of an intravaginal device. Theobstruction 312 can have one dimension greater than one dimension of theaperture 314. The obstruction 312 can have dimensions, such as, forexample, an outer length, an outer height, and an outer width. One ofthe obstruction 312 dimensions can be greater than the largest dimensionof the aperture 314.

As shown in FIGS. 9A and 9B, a portion of the withdrawal assembly 28 canbe contained by the intravaginal device. The obstruction 312 can becontained inside the pessary device 10. The obstruction 312 can becontained inside the pessary device 10 by any opening to the hollowregion 220 of the pessary device 10. The obstruction 312 can becontained inside the intravaginal device by the shape of the device. Forexample, the obstruction 312 can be contained inside the device by awaist of the intravaginal device itself. The obstruction 312 can movefreely within the portion of the hollow region 220 containing theobstruction 312. The obstruction 312 can at least partially blocks theaperture 314. The withdrawal member 310 crosses through the aperture314.

As shown in FIGS. 9B and 9A, the obstruction 312 can have one dimensiongreater than one dimension of the aperture 314. The obstruction 312 canhave dimensions, such as, for example, an outer length, an outer height,and an outer width. One of the obstruction 312 dimensions can be greaterthan the smallest dimension of a transverse axis area running along alongitudinal axis (L) of a hollow intravaginal device.

As shown in FIG. 9C, the hollow region 220 can contain one or moreprotuberances 260 that can be integral or non-integral to the inner wall240. The protuberances 260 can cross the longitudinal axis of thepessary device. The protuberances 260 can contact at the longitudinalaxis or between the longitudinal axis and the inner wall. Theprotuberances 260 can interlock with each other. The obstruction 312 canbe contained inside the intravaginal device by internal protuberances260 within the hollow interior of the device. The obstruction 312 canmove freely inside the hollow region 220 of the device. The withdrawalmember 310 crosses through the aperture 314.

As shown in FIG. 9D, the withdrawal assembly 28 can be joined to theintravaginal device by friction. A portion of the withdrawal assembly 28can be part of the outer profile of the pessary device 10. Thewithdrawal member 310 crosses through the aperture 314.

As shown in FIG. 9E, the hollow region 220 can have a first end section222, a central section 224, and a second end section 226. The hollowregion 220 can contain one or more protuberances 260 in the form of afirst pair of protuberances 262 and a second pair of protuberances 264.In an embodiment, the first end section 222 has a first pair ofprotuberances 262 and a second pair of protuberances 264. In anembodiment, the second end section 224 has a first pair of protuberances262 and a second pair of protuberances 264. The first pair ofprotuberances 262 can extend from an end of the pessary device towardsthe second pair of protuberances 264. The second pair of protuberances264 can extend parallel the aperture at the end of the pessary deviceand are flexible. The second pair of protuberances 264 allow anobstruction to move past them when inserted through the opening. Once anobstruction has passed the second pair of protuberances 264, the firstset of protuberances 262 prevent the second pair of protuberances 264from bending towards the opening thereby maintaining the obstruction 312inside the hollow region 220.

As shown in FIG. 9E, the pessary device hollow region may be symmetricabout the transverse axis. In an embodiment, the first end section 222second pair of protuberances 264 and the second end section 226 secondpair of protuberances 264 define the central section 224 of the hollowregion 220. In an embodiment, the obstruction may not have a crosssection larger than the opening or aperture and may not be larger inlength than the central section 224 of the hollow region 220.

In an embodiment, the second pair of protuberances 264 have a notchequal or greater than the cross section of the withdrawal member 310. Inan embodiment as shown in FIG. 9E, the second pair of protuberance 264are offset along the longitudinal axis of the hollow interior.Offsetting the protuberances creates a path for the withdrawal member310 to an aperture of the pessary device.

The pessary device 10 can include an overwrap 300, such as, for example,as shown in FIG. 10.

The pessary device can be inserted in any suitable manner, such as, forexample, using an applicator. FIG. 11 shows an applicator 410 thatincludes an insertion member 420 and a plunger 440. The insertion member420 has an insertion end 421 and a withdrawal end 422 opposite theinsertion end 421. The insertion member 420 also can include a barrelregion 450 adapted to contain a pessary device, and a grip region 430that can be an indentation region 424 provided opposite the insertionend 421, such as, e.g., proximal to the withdrawal end 422. The gripregion 430 can include one or more grip elements 423.

The pessary device can be non-expandable. A portion or region of thepessary device can flex or be deformed, such as, for example, in theregion having the minimum diameter, but the pessary device does notexpand and returns to the original configuration after deformation. Assuch, the pessary device does not include any mechanical or other meansthat requires the user to change the size or shape of the pessary deviceduring use, such as, for example, before or after insertion or prior towithdrawal. This provides for a pessary device that has a size uponwithdrawal that is the same as the size during use, which can providefor improved comfort during use and withdrawal.

The pessary device can have a pressure region that has the maximumdiameter of the pessary, such as, for example, at the base or at thetop, that extends between the anterior vaginal wall and the posteriorvaginal wall of a consumer to provide pressure on the urethra throughthe vaginal wall. In addition, the pessary device can have a secondpressure region having an increased diameter as compared to the minimumdiameter that can provide pressure on the urethra through the vaginalwall at a point apart from the first pressure region. The first pressureregion and the second pressure region can be separated by any suitabledistance, such as, for example, by at least about 5 mm, at least about10 mm, at least about 15 mm, at least about 20 mm, at least about 25 mm,at least about 30 mm, at least about 35 mm, at least about 40 mm, atleast about 45 mm, or at least about 50 mm.

The pessary device can have any suitable number of pressure regions,including for example, two pressure regions, such as, for example, fouror fewer pressure regions, three or fewer pressure regions, two or fewerpressure regions, one pressure region, or any other suitable number ofpressure regions.

The pressure region or regions can be any suitable shape, such as, forexample, a convex shape that provides pressure to the vaginal wall,including, for example, a lobe. The pressure region or regions can havea substantially circular cross-section. The pessary device also caninclude a minimum diameter region that is a flexile region that canprovide flexibility to the pessary device, such as, for example, byallowing bending or movement at the flexile region. The flexile regioncan be any suitable shape, such as, for example, concave, indented, orthe like, and can have any suitable cross-section, such as, for example,a substantially circular cross-section. The pessary device can include aflexile region provided between two pressure regions.

The pessary device can provide resistance to force when placed inside awoman's vagina. For example, when the pessary device is inserted intothe vagina, increases in abdominal pressure can act as a force on thepessary device through the vaginal wall. When the pessary device isdisposed in the vagina lengthwise, that is, with the top of the pessarydevice positioned toward the cervix, the bottom of the pessary devicepositioned toward the introitus, and the length of the pessary devicegenerally aligned with the length of the vagina, increases in abdominalpressure can act on the side of the pessary device, perpendicular to thelength of the pessary device. Of course, increases in abdominal pressurecan act on other regions of the pessary device, in addition oralternatively to acting on the side of the pessary device, including forexample, when the pessary device is inserted into the vagina in anorientation other than lengthwise.

Despite its small size, the pessary device can provide a resistance toforce of greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi under about 2 newtons offorce. For example, the pessary device can provide a resistance to forceof greater than about 20 psi under about 2 newtons of force and greaterthan about 25 psi under about 3 newtons of force. The pessary devicealso can resist compression under pressure. For example, the pessarydevice can compress less than about 20% under about 2 newtons of force,less than about 15% under about 2 newtons of force, less than about 14%under about 2 newtons of force, less than about 13% under about 2newtons of force, less than about 12% under about 2 newtons of force,less than about 11% under about 2 newtons of force, less than about 10%under about 2 newtons of force, less than about 9% under about 2 newtonsof force, less than about 8% under about 2 newtons of force, less thanabout 7% under about 2 newtons of force, less than about 6% under about2 newtons of force, less than about 5% under about 2 newtons of force,less than about 4% under about 2 newtons of force, less than about 3%under about 2 newtons of force, less than about 2% under about 2 newtonsof force, or less than about 1% under about 2 newtons of force. Forexample, the pessary device can compress less than about 20% under about2 newtons of force, less than about 15% under about 2 newtons of force,less than about 14% under about 2 newtons of force, less than about 13%under about 2 newtons of force, less than about 12% under about 2newtons of force, less than about 11% under about 2 newtons of force,less than about 10% under about 2 newtons of force, less than about 9%under about 2 newtons of force, less than about 8% under about 2 newtonsof force, less than about 7% under about 2 newtons of force, less thanabout 6% under about 2 newtons of force, less than about 5% under about2 newtons of force, less than about 4% under about 2 newtons of force,less than about 3% under about 2 newtons of force, less than about 2%under about 2 newtons of force, or less than about 1% under about 2newtons of force.

The pessary devices can provide a varied resistance to force along thelongitudinal axis of the pessary device. For example, the pessary devicecan provide a resistance to force that is greater at the maximumdiameter regions and smaller at the minimum diameter regions. Inaddition, the pessary device can compress differently along thelongitudinal axis at different regions. For example, when force isapplied to the side of the pessary, the minimum diameter region cancompress at least about 5% more than the maximum diameter region underthe same amount of pressure (for example, under about 200 g/m² offorce), at least about 10% more than the maximum diameter region underthe same amount of pressure, at least about 15% more than the maximumdiameter region under the same amount of pressure, at least about 20%more than the maximum diameter region under the same amount of pressure,or at least 25% more than the maximum diameter region under the sameamount of pressure. Any suitable amount of force can be applied, suchas, for example, from about 200 g/m² of force to about 1500 g/m² offorce, from about 200 g/m² of force to about 1400 g/m² of force, fromabout 300 g/m² of force to about 1200 g/m² of force, or from about 400g/m² of force to about 800 g/m² of force.

The amount of resistance to force and the amount of compression underforce provided by the pessary device as a whole or provided by thedifferent regions of the pessary device can be measured in any suitablemanner. For example, one suitable method employs a Universal ConstantRate Elongation/Tensile Tester with computer interface (MTS, EdenPrairie, Minn.). The method measures the force required to compress thepessary device resting on its side at 0.8 mm at a rate of 20 mm per min.For this method, the load probe tip is 5 mm in diameter and the tip issemi-spherical in shape. In addition, the resting fixture is acylindrical steel plate 152 mm in diameter and 13 mm thick. The pessarydevice is placed on the steel table and the crosshead moves at 20mm/min. When a force of 2 grams is exhibited on the pessary device, thecrosshead automatically zeroes out and moves an additional 0.8 mm. Theprobe cycles back, and data is acquired at a rate of 100 Hz. This methodmeasures the peak force in grams versus the amount of compression in mm.For pessary devices having varying diameters or widths, such as, forexample, pessary devices having a maximum diameter or width and aminimum diameter or width, resistance to force at the different regionscan be measured using this method. For example, for a pessary device asshown in FIGS. 7A and 7B, resistance to force at the maximum diameterregions D₁ and D₃ can be measured using a steel plate that is larger insize than the pessary device as the resting fixture. Resistance to forceat the minimum diameter region D2 can be measured using a single rodthat contacts the minimum diameter region but not the maximum diameterregions.

Generally, the pressure region can be resistant such that the pressureregion can provide pressure to the vaginal wall. The pressure regionprovides resistance under high stress pressures typical of the humanvagina, such as, for example, by providing a maximum pressure to theurethra through the vaginal wall greater than about 5 psi, such as, forexample, greater than about 10 psi, greater than about 15 psi, greaterthan about 20 psi, or greater than about 25 psi. In addition, thepressure region can provide a maximum urethral closure of greater thanabout 1.0 mm, such as, for example, greater than about 1.1 mm, greaterthan about 1.2 mm, greater than about 1.3 mm, greater than about 1.4 mm,such as, for example, greater than about 1.5 mm, greater than about 1.6mm, greater than about 1.7 mm, greater than about 1.8 mm, or greaterthan about 1.9 mm. In addition, or alternatively, the pressure regioncan compress less than about 1 mm when measured under 0.5 psi when theforce is applied from one side of the pressure region to the oppositeside of the pressure region at the region of maximum diameter in thedirection perpendicular to the longitudinal axis.

The flexile region, on the other hand, is more flexible than andprovides less resistance than the pressure region. Addition of theflexile region can allow the pessary device to flex in the longitudinaldirection as well at the lateral direction. For example, the pessarydevice can compress more than about 1 cm when measured under 0.5 psiwhen the force is applied from the top to the base along thelongitudinal axis. In addition, or alternatively, the flexile region canprovide a bending region that facilitates the pessary device bendingfrom side to side.

The pessary device can be a unitary construction. For example, thepessary device can include a continuous outer shell that defines theentire exterior surface of the pessary device. The outer shell can besmooth or textured. The outer shell can be permeable to fluid, such as,for example, by the inclusion of holes, pores, or other suitableopenings. Alternatively, the outer shell can be impermeable to fluidsuch that fluid cannot enter the device. In addition, the pessary devicecan include an opening in the top and/or base. The pessary device caninclude an opening in the top and/or base and the outer shell is notpermeable to fluid such that fluid cannot enter the device exceptthrough the opening in the top and/or base. The opening in the topand/or base to the hollow interior may have engaging members. Theengaging members may be triangles, half circles, quarter circles, and/orgeometric shapes with points. Engaging members are further described inU.S. Patent Publication No. 2014/0000628 A1, filed Jun. 29, 2012.

The pessary device can be constructed from two or more pieces. The twoor more pieces can snap fit together to form a continuous outer shellthat defines the entire exterior surface of the pessary device. Inaddition, the pessary device can include an aperture in the top and/orbase.

Suitable pessary devices can have a hollow interior. The pessary devicecan have an outer periphery defining a total area of the device and aninner periphery defining an open area of the device. The open area canbe any suitable size, such as, for example, between about 5% to about95% of the total area, such as, for example, from about 10% to about 90%of the total area, from about 15% to about 85% of the total area, orfrom about 20% to about 80% of the total area. In addition, the pessarydevice also can have a wall thickness that is suitable to maintain thepessary configuration. The wall thickness can be greater than about 1mm, such as for example, about 2 mm, about 3 mm, about 4 mm, about 5 mm,or greater. The wall thickness can be constant or varied along thelength of the pessary device and/or around the circumference of thepessary device.

The pessary device can have any suitable shape having a varied diameteralong the longitudinal axis, such as, for example, a shape having avaried diameter that is symmetrical with respect to the longitudinalaxis, such as, for example, a teardrop, an apple, a pear, an hourglass,a waisted cylinder, a figure-8 shape, a peanut shape, a heart-shape, alight bulb shape, a bottle shape, a vase shape, or any other suitableshape. In addition, the shape can have a varied diameter and can besymmetrical with respect to both the longitudinal and lateral axis, suchas, for example, an hourglass, a waisted cylinder, a figure-8 shape, apeanut shape, or any other suitable shape. Alternatively, the pessarydevice can have an asymmetrical shape, such as, for example, a B-shapeor a P-shape. The pessary device can be symmetrical at one region andasymmetrical at another region, such as, for example, where the pessarydevice has a symmetrical pressure region and an asymmetrical flexileregion. Generally, the pessary device can have a varying diameter thatcan provide varying pressure along the user's urethra. For example, thepessary device can have a convex portion that can correspond to thepressure region. In addition, the pessary device can have a minimumdiameter region that can be a concave region. The concave region cancorrespond to the flexile region.

The pessary device can be hourglass shaped. For example, as shown inFIG. 7, the pessary device can have upper and lower portions joinedtogether by a waistline portion, with the upper and lower portionshaving diameters that are both greater than a diameter of the waistlineportion such that the pessary device has a generally hourglassconfiguration. In this configuration, the upper portion of the pessarydevice can have a top and the lower portion of the pessary device canhave a base, and the pessary device can have sloping upper and lowerwall sections joining the top and the base with the waistline portion.In addition, the waistline portion can include the minimum diameter ofthe pessary device. The upper and lower portions can have generallycoequal maximum diameters, or the upper and lower portions can havedifferent maximum diameters, such as, for example, where the upperportion has a maximum diameter greater than the lower portion or wherethe lower portion has a maximum diameter greater than the upper portion.

Generally, the pessary device includes at least one maximum diameter andat least one minimum diameter, where the minimum diameter is smallerthan the maximum diameter. The pessary device can include a firstportion having a maximum diameter, a second portion having a maximumdiameter, and a third portion that has a minimum diameter. The maximumdiameter of the first portion and the maximum diameter of the secondportion can be separated by a distance that is greater than about 10% ofthe length of the pessary device, such as, for example, by a distancegreater than about 5 mm, greater than about 10 mm, greater than about 15mm, greater than about 20 mm, greater than about 25 mm, greater thanabout 30 mm, greater than about 35 mm, greater than about 40 mm, greaterthan about 45 mm, or more. The pessary device can provide pressure atmid-urethra, the bladder neck, or both. In addition, the pessary devicecan provide higher pressure at the mid-urethra, the bladder neck, orboth and provides lower pressure at the area between the mid-urethra andthe bladder neck. For example, the pressure region can provide pressureat levels about 25% higher than the pressure provided by the flexileregion, such as, for example, at levels about 30% higher, about 35%higher, about 40% higher, about 45% higher, about 50% higher, about 55%higher, about 60% higher, or more.

The pessary device can have a slope from the maximum diameter to theminimum diameter. Any suitable slope can be used, including for example,about 0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, about 1.5 mm,about 2 mm, about 2.5 mm, about 3 mm, about 4 mm, about 5 mm, about 6mm, about 7 mm, about 8 mm, or more, such as, for example, a slope fromabout 0.25 mm to about 5 mm, or a slope from about 0.5 mm to about 4 mm,or any other suitable range.

Suitable pessary devices are typically smaller in size than conventionalpessary devices. For example, the pessary devices have a maximumdiameter, a length, and/or a volume that is smaller or less than that ofconventional pessary devices.

The pessary devices can have any suitable maximum diameter, such as, forexample, a maximum diameter of less than 55 mm, such as, for example,less than 50 mm, less than 45 mm, less than 40 mm, less than 35 mm, lessthan 34 mm, less than 33 mm, less than 32 mm, less than 31 mm, less than30 mm, less than 29 mm, less than 28 mm, less than 27 mm, less than 26mm, less than 25 mm, less than 24 mm, less than 23 mm, less than 22 mm,less than 21 mm, less than 20 mm, less than 19 mm, less than 18 mm, lessthan 17 mm, less than 16 mm, less than 15 mm, less than 14 mm, less than13 mm, less than 12 mm, less than 11 mm, or less than 10 mm, including,for example, a maximum diameter of from about 10 mm to about 35 mm, fromabout 10 mm to about 25 mm, from about 13 mm to about 25 mm, or fromabout 15 mm to about 22 mm. The maximum diameter or width is typicallymeasured at the widest portion of the pessary device substantiallyperpendicular to the longitudinal axis.

The pessary devices can have any suitable minimum diameter that issmaller than the maximum diameter, including, for example, a minimumdiameter from about 40% to about 95% of the maximum diameter, from about40% to about 90% of the maximum diameter, from about 40% to about 85% ofthe maximum diameter, from about 40% to about 80% of the maximumdiameter, from about 45% to about 75% of the maximum diameter, or fromabout 50% to about 70% of the maximum diameter, such as, for example,about 45% of the maximum diameter, about 50% of the maximum diameter,about 55% of the maximum diameter, about 60% of the maximum diameter,about 65% of the maximum diameter, or about 70% of the maximum diameter.

The maximum diameter and the minimum diameter can be separated by anysuitable distance, such as, for example, by about 5 mm, about 10 mm,about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 35 mm, about40 mm, about 45 mm, about 50 mm, or any other suitable distance.

The pessary devices can have any suitable length, such as, for example,a length from about 35 mm to about 60 mm, about 40 mm to about 55 mm, orabout 40 mm to about 50 mm, such as, for example, a length about 35 mm,about 36 mm, about 37 mm, about 38 mm, about 39 mm, about 40 mm, about41 mm, about 42 mm, about 43 mm, about 44 mm, about 45 mm, about 46 mm,about 47 mm, about 48 mm, about 49 mm, or about 50 mm. The length istypically measured substantially parallel to the longitudinal axis ofthe pessary device.

Generally, the pessary device can have a weight of less than about 10grams, less than about 9 grams, less than about 8 grams, less than about7 grams, less than about 6 grams, less than about 5 grams, less thanabout 4 grams, less than about 3 grams, less than about 2 grams, orabout 1 gram, including for example, a weight of from about 1 gram toabout 7 grams, or from about 2 grams to about 6 grams, or from about 3grams to about 5 grams.

Pessary devices can be fabricated using any suitable materials andmethods. For example, pessaries can be formed from polymeric materials,such as, for example, polycarbonate, polyester, polyethylene,polyacrylamide, polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, nylon, silicone, or mixtures or blends thereof, ormetallic materials. In certain embodiments, the pessary devices are notformed from absorbent material such as, for example, fibrous material orabsorbent foam.

Pessary devices can be formed in any suitable manner, such as, forexample, using injection molding, blowmolding, or other suitable methodsof forming the pessary device. Pessary devices can be assembled by snapfitting two or more pieces together.

The pessary device can have one or more protuberances inside the hollowinterior. The pessary device can have a plurality of protuberances.Protuberances can be integral or non-integral to the pessary device.Non-integral protuberances can be attached to the inner walls of thepessary device by any means commonly known to one of ordinary skill inthe art including, such as, for example, adhesives and/or heat.Protuberances can be in the shape of a nub, a hook, a disc, a rod,triangle, pyramid, and/or any volumetric shape.

A protuberance can be used to cross an external opening to the pessarydevice. A protuberance can be used to connect one side of the hollowinterior to the opposite side of the hollow interior crossing thelongitudinal axis. One or more protuberances can form a bridge crossingthe longitudinal axis. Two or more protuberances can meet at thelongitudinal axis. Two or more protuberances can meet at a point betweenthe longitudinal axis and the inner wall along the transverse axis.Protuberances can be located at different points along the longitudinalaxis.

Two or more protuberances can meet and interlock within the hollowinterior by any method known, such as, for example, by lock and key,hooking parts, ball and socket, and/or friction. Two or moreprotuberances can be symmetrical to each other within the hollowinterior along one or both of the longitudinal and/or transverse axis.

Protuberances can be made from polymeric materials, such as, forexample, polycarbonate, polyester, polyethylene, polyacrylamide,polyformaldehyde, polymethylmethacrylate, polypropylene,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, nylon, silicone, or mixtures or blends thereof, ormetallic materials.

The pessary device can be covered by an overwrap. The overwrap can benon-absorbent or absorbent and can include any suitable material, suchas, for example, a fibrous nonwoven material comprising natural,synthetic, or a blend of natural and synthetic fibers. Suitablesynthetic fibers can include, e.g., fibers such as polyester,polyolefin, nylon, polypropylene, polyethylene, polyacrylic, celluloseacetate, polyhydroxyalkanoates, aliphatic ester polycondensates,bicomponent fibers and/or mixtures thereof. Natural fibers can include,e.g., rayon and those commonly known to be non-synthetic and of naturalorigin such as cotton. The fibers can have any suitable cross-sectionalshape, such as, e.g., round, tri-lobal, multi-lobal, delta, hollow,ribbon-shaped, and/or any other suitable shape, or mixtures thereof.Fibers with any suitable diameter can be used, such as, e.g., from about0.5 to about 50 microns, such as, e.g., from about 1 to about 30microns, such as, e.g., from about 10 to about 25 microns. Fiberdiameter can be determined using any suitable means; however, fornon-round fibers, diameter can typically be determined by reference tothe diameter of a fiber with the same cross-sectional area as thenon-round fiber.

The overwrap can be made by any number of suitable techniques and canhave any suitable basis weight. Suitable techniques include, forexample, carding, meltblowing, spunbonding, spunlacing, air laying, andthe like. For example, the overwrap can be formed using bonding methods,such as, e.g., thermal, ultrasonic, resin, through-air bonding,hydroentangling, and/or needling. The basis weight of the overwrap canbe any suitable weight, such as, e.g., from about 10 to about 60 gramsper square meter (gsm), such as, e.g., from about 15 to about 30 gsm. Inaddition, the overwrap can be hydrophilic or hydrophobic.

The overwrap can be joined to the pessary device by any variety ofmeans. The overwrap can be joined to itself or to the pessary device.For example, one portion of overwrap can be joined to an opposed portionof the overwrap or to the pessary device using any suitable adhesive orheat pressure bonding means. Such adhesive can extend continuously alongthe length of attachment or it can be applied in a non-continuousfashion at discrete intervals. Heat bonding includes thermally bonding,fusion bonding, or any other suitable means for joining such materials.

The pessary device can include a withdrawal assembly.

The intravaginal device can be inserted using an applicator that caninclude an insertion member and a plunger. The insertion member can havean insertion end and a withdrawal end opposite the insertion end. Theinsertion member also can include a barrel region adapted to contain theintravaginal device, and a grip region that can be an indentation regionprovided opposite the insertion end, such as, e.g., proximal to thewithdrawal end.

The insertion member and/or plunger can be constructed from any suitablematerial. Suitable materials include, for example, paper, paperboard,cardboard, cellulose, such as, e.g., molded cellulose, or anycombinations thereof, polyethylene, polypropylene, polybutylene,polystyrene, polyvinylchloride, polyacrylate, polymethacrylate,polyacrylonitrile, polyacrylamide, polyamide, nylon, polyimide,polyester, polycarbonate, polylactic acid, poly hydroxyalkanoate,ethylene vinyl acetate, polyurethane, silicone, derivatives thereof,copolymers thereof, mixtures thereof, or any suitable smooth plasticmaterial. Examples of suitable materials are disclosed in, e.g., U.S.Pat. Nos. 5,346,468 and 5,558,631. Additives can be included in thematerial to alter or enhance certain material properties. Suitableadditives include, for example, mold release agents, slip agents,surface energy modifiers, pearlescent agents, and/or any other suitableadditives. The insertion member also or alternatively can be coated witha substance to give it a high slip characteristic, such as, e.g., withwax, polyethylene, a combination of wax and polyethylene, cellophane,clay, mica, and other lubricants that can facilitate comfortableinsertion. Alternatively, or in addition, the insertion member caninclude a textured surface. Texture can be provided in any suitablemanner, such as, e.g., by designing texture into or adding texture tothe insertion member.

The insertion member can include a grip region, such as, for example, anindentation region. The grip region can have a plurality ofthree-dimensional surface elements, such as, e.g., projections, rings,ridges, ribs, embossments, depressions, grooves, and/or other grippingstructures. The three-dimensional surface elements can be provided inany suitable manner, such as, e.g., by the addition of material, and/orby impressing, such as, e.g., by embossing, or compressing the surfaces.For example, the indentation region can include one or more flattenedsides and/or one or more spaces for a decorative marking or a character,such as, e.g., an embossed and/or printed marking or character. Inaddition, or alternatively, the surfaces of the indentation region caninclude a material that can provide a frictional resistance for theuser's fingers during the insertion of the applicator into the body.Suitable materials that can provide friction include, for example,abrasive materials, high wet coefficient of friction materials, pressuresensitive adhesives, or any combinations thereof.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

All documents cited in the Detailed Description of the Invention are, inrelevant part, incorporated herein by reference; the citation of anydocument is not to be construed as an admission that it is prior artwith respect to the present invention. To the extent that any meaning ordefinition of a term in this document conflicts with any meaning ordefinition of the same term in a document incorporated by reference, themeaning or definition assigned to that term in this document shallgovern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. A pessary device comprising an outer shell, ahollow region, and an aperture to the hollow region; wherein the hollowregion comprises a withdrawal assembly and at least a first pair ofprotuberances and a second pair of protuberances; wherein the withdrawalassembly comprises a withdrawal member and an obstruction; wherein thesecond pair of protuberances at least partially blocks the aperture; andwherein the first pair of protuberances prevent the second pair ofprotuberances from bending towards the aperture.
 2. The pessary deviceof claim 1, wherein the obstruction main body has a shape comprising alength, a width, and a height; wherein at least one of the length,width, or height, is greater in dimension than the other two dimensions.3. The pessary device of claim 1, wherein the obstruction comprises oneor more interconnected parts.
 4. The pessary device of claim 1, whereinthe second pair of protuberances are flexible.
 5. The pessary device ofclaim 1, wherein the obstruction comprises slots enabled to hold thewithdrawal member.
 6. The pessary device of claim 1, wherein the secondpair of protuberances are offset along the longitudinal axis.
 7. Thepessary device of claim 1, wherein the obstruction has a compressedshape and an expanded shape.
 8. The pessary device of claim 1, whereinthe obstruction comprises an outer length, an outer height, and an outerwidth; and wherein at least one of the obstruction outer length,obstruction outer width, or obstruction outer height is greater than thelargest dimension of the aperture.
 9. A pessary device comprising a top,a base, a length, a longitudinal axis, a transverse axis, a hollowregion, an aperture to the hollow region, and a withdrawal assembly;wherein the withdrawal assembly comprises a withdrawal member and anobstruction; wherein the obstruction comprises an outer length, an outerheight, and an outer width; wherein at least one of the obstructionouter length, obstruction outer width, or obstruction outer height isgreater than the largest dimension of the aperture; and wherein thehollow region is symmetric about a transverse axis; wherein the hollowregion comprises a first end section, a central section and a second endsection; wherein the first end section comprises a pair ofprotuberances; wherein the second end section comprises a pair ofprotuberances; and wherein the first end section pair of protuberancesand the second end section pair of protuberances define the centralsection of the hollow region.
 10. The pessary device of claim 9, whereinthe first end section comprises a first pair of protuberances and asecond pair of protuberances.
 11. The pessary device of claim 10,wherein the second pair of protuberances are flexible.
 12. The pessarydevice of claim 11, wherein the first pair of protuberances prevent thesecond pair of protuberances from bending towards the aperture.
 13. Thepessary device of claim 9, wherein the obstruction comprises slotsenabled to hold the withdrawal member.
 14. A pessary device comprisingan outer shell, a hollow region, and an aperture to the hollow region;wherein the hollow region is symmetric about a transverse axis; whereinthe hollow region comprises a first end section, a central section, anda second end section; wherein the hollow region comprises a withdrawalassembly; wherein the withdrawal assembly comprises a withdrawal memberand an obstruction; wherein the first end section comprises a first pairof protuberances and a second pair of protuberances; wherein the secondpair of protuberances at least partially blocks the aperture; whereinthe second end section comprises a third pair of protuberances; andwherein the first end section second pair of protuberances and thesecond end section third pair of protuberances define the centralsection of the hollow region.
 15. The pessary device of claim 14,wherein the obstruction main body has a shape comprising a length, awidth, and a height; wherein at least one of the length, width, orheight, is greater in dimension than the other two dimensions.
 16. Thepessary device of claim 14, wherein the obstruction comprises one ormore interconnected parts.
 17. The pessary device of claim 14, whereinthe second pair of protuberances are flexible.
 18. The pessary device ofclaim 14, wherein the obstruction comprises slots enabled to hold thewithdrawal member.
 19. The pessary device of claim 14, wherein thesecond pair of protuberances are offset along the longitudinal axis. 20.The pessary device of claim 14, wherein the obstruction has a compressedshape and an expanded shape.
 21. The pessary device of claim 14, whereinthe obstruction comprises an outer length, an outer height, and an outerwidth; and wherein at least one of the obstruction outer length,obstruction outer width, or obstruction outer height is less than thelargest dimension of the central section of the hollow region.
 22. Thepessary device of claim 14, wherein the obstruction comprises an outerlength, an outer height, and an outer width; and wherein at least one ofthe obstruction outer length, obstruction outer width, or obstructionouter height is greater than the largest dimension of the aperture.